Sufentanil Intranasal

NCT ID: NCT04137198

Last Updated: 2021-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-22

Study Completion Date

2025-09-01

Brief Summary

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Study of the effects of intranasal sufentanil on patients presenting to the emergency department with acute post-traumatic pain.

Detailed Description

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In this study, patients presenting to the emergency department with post-traumatic pain of 7 or more on the visual analog pain scale, since less than 24 hours, in the limbs, spine or thorax are randomized in a control arm or an interventional arm.

The patients in the control arm will receive the institution's classical analgetic protocol level 1 and 3, the patients in the intervention arm are given classical level 1 medication as well as intranasal Sufentanil.

Pain is then measured using the Visual Analogue Pail Scale at 15-20 minutes and at 60 minutes. At both these time points, adverse effects and vitals are also assessed.

Conditions

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Emergencies Pain, Acute Analgesia Sufentanil

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control

classic analgetic protocol

Group Type NO_INTERVENTION

No interventions assigned to this group

intervention

intranasal Sufentanil

Group Type EXPERIMENTAL

Sufentanil

Intervention Type DRUG

intranasal administration of Sufentanil Forte 0,5mcg/kg as first dose and 0,3mcg/kg as titration doses

Interventions

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Sufentanil

intranasal administration of Sufentanil Forte 0,5mcg/kg as first dose and 0,3mcg/kg as titration doses

Intervention Type DRUG

Other Intervention Names

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Sufenta Forte

Eligibility Criteria

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Inclusion Criteria

* posttraumatic pain + lasting for less than 24 hours + with an analog visual pain scale of 7/10 or more

Exclusion Criteria

* pregnant
* \<18 years
* prisoners
* lesions of head, face or abdomen
* no consent given or possible
* pain not scorable
* known drug abuse or substitution therapy
* chronic level 3 pain medication
* intake of level 3 \< 8 hours
* intoxicated patient
* allergy or intolerance to opiates
* renal or hepatic insufficiency
* \< 50kg body weight
* hemodynamic instability
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Saint Pierre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Saint Pierre

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Bernard Kreps, MD

Role: CONTACT

+3225353495

Stefano Malinverni, MD

Role: CONTACT

Facility Contacts

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Stefano Malinverni, MD

Role: primary

+3225354051

References

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Malinverni S, Kreps B, Lucaccioni T, Bouazza FZ, Bartiaux M, Plumacker A, Pascu A, Youatou Towo P. Effect of intranasal sufentanil on acute post-traumatic pain in the emergency department: a randomised controlled trial. Emerg Med J. 2024 Jan 22;41(2):83-88. doi: 10.1136/emermed-2023-213353.

Reference Type DERIVED
PMID: 37770120 (View on PubMed)

Other Identifiers

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SUFIN002

Identifier Type: -

Identifier Source: org_study_id

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